Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Adalimumab (Humira)

Adalimumab (Humira) is an anti-TNF agent similar to infliximab and decreases inflammation by blocking tumor necrosis factor (TNF-alpha). In contrast to infliximab, adalimumab is a fully humanized anti-TNF antibody (no mouse protein). Adalimumab is administered subcutaneously (under the skin) instead of intravenously as in the case of infliximab.

Rheumatologists have been using adalimumab for treating inflammation of the joints in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Four clinical trials (involving almost 1,500 patients) comparing adalimumab to placebo, have demonstrated that adalimumab is also effective in treating inflammation in the intestines of patients with Crohn's disease and in reducing signs and symptoms of Crohn's disease. Adalimumab is not only effective in reducing disease activity but has also recently been found to be helpful in treating arthritis and arthralgias in patients with moderately or severely active Crohn's disease5.

Adalimumab is comparable to infliximab in effectiveness and safety for inducing and maintaining remission in patients suffering from Crohn's disease. Adalimumab is also effective in healing Crohn's anal fistulas. Adalimumab has been shown to be effective for patients who either failed or cannot tolerate infliximab.

The Food and Drug Administration approved Humira (adalimumab) in February 2007, to treat adult patients with moderately to severely active Crohn's disease. Adalimumab (Humira) is administered subcutaneously every two weeks.

The side effects of adalimumab (Humira)

Adalimumab generally is well-tolerated. The most common side effect is skin reactions at the site of injection with swelling, itching, or redness. Other common side effects include upper respiratory infections, sinusitis, and nausea.

TNF-alpha is an important protein for defending the body against infections. Adalimumab, like infliximab, increases the risk of infection. There have been cases of tuberculosis (TB) reported after the use of infliximab and adalimumab. It now is recommended that patients be tested for TB prior to receiving these agents. Patients who previously had TB should inform their physician of this before they receive these agents. Adalimumab, like infliximab, can aggravate and cause the spread of an existing infection. Therefore, it should not be given to patients with pneumonia, urinary tract infection, or abscess (localized collection of pus).

Rare cases of lymphoma (cancer of the lymphatic system) have been reported with the use of adalimumab. Rare cases of nervous system inflammation have been reported with the use of adalimumab. The symptoms may include numbness and tingling, vision disturbances, weakness in legs. Some patients receiving adalimumab may rarely develop symptoms that mimic systemic lupus; these symptoms include skin rash, arthritis, chest pain, or shortness of breath. These lupus-like symptoms resolve after stopping the drug.

There are some reports of worsening heart disease such as heart failure in patients who have received infliximab or adalimumab. The precise mechanism and role of these agents in the development of this side effect is unclear. As a precaution, individuals with heart disease should inform their physician of this condition before receiving infliximab or adalimumab.

Severe allergic reactions with rash, difficulty breathing, and severe low blood pressure or shock are rare, but serious allergic reactions can occur either after the first injection or after many injections. Patients experiencing symptoms of serious allergic reactions should seek emergency care immediately.